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FDA批准“速效伟哥”Stendra,15分钟见效!立竿见影!

来源:生物谷 2014-09-19 10:31

2014年9月18日讯 /生物谷BIOON/ --美国生物医药公司Auxilium和Vivus近日宣布,勃起功能障碍(ED)药物Stendra(avanfil)补充新药申请(sNDA)获FDA批准,该药是FDA批准的唯一一种起效时间短至15分钟的ED药物,被誉为“速效伟哥”,特点是立竿见影,服药15分钟后即可见效,可实现足够长时间的勃起帮助完成性生活。而辉瑞(Pfizer)的重磅药物万艾可(Viagra,伟哥),需在性生活前30分钟-1个小时服药。

Stendra于2012年首次获批时的处方信息推荐性生活前30分钟服药,该药有多个剂量可供选择(包括50mg、100mg和200mg片剂),同时可以配合食物及适量饮酒服药。在临床试验(TA-501)中,与安慰剂相比,Stendra可在约15分钟内帮助更多的ED患者实现勃起,并维持足够长的时间成功完成性生活。

Stendra属于一类名为5型磷酸二酯酶(PDE5)抑制剂的处方药,用于18岁及以上功能勃起障碍(ED)患者,帮助增加血流流向阴茎。Vivus拥有Stendra在全球的开发和商业化权利(除某些亚洲国家和环太平洋地区),Auxilium则拥有Stendra在美国和加拿大的独家销售权,同时赛诺菲拥有在非洲、中东、土耳其、独立国家联合体(包括俄罗斯)的商业化授权。Stendra在欧盟以品牌名Spedra销售。

Auxilium公司周三表示,不会撤回对加拿大眼科制药商QLT公司的收购要约,此前几天Auxilium公司便已宣布裁员计划,坚定不移地朝兼并QLT公司的目标前进,一旦兼并完成,Auxilium公司的的税率将从目前美国35%降至加拿大的15%。在同一天,Auxilium公司收到了美国制药商远藤国际(Endo International)不请自来的22亿美元收购要约,Auxilium已启动了一项“毒丸计划”,QLT公司也已同意该计划,以抵制远藤的“敌意收购”。

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英文原文:Faster-acting erectile dysfunction drug gets FDA approval

(Reuters) - An erectile dysfunction drug that reduces by half the time patients need to take the pill before sexual activity has been approved by the U.S. Food and Drug Administration.

Developed by Auxilium Pharmaceuticals Inc and Vivus Incs, the drug, Stendra, is the first FDA-approved erectile dysfunction drug that can be taken about 15 minutes prior to sexual activity.

Pfizer Inc's blockbuster erectile dysfunction drug, Viagra, can be taken about an hour before sex.

Stendra, first approved in 2012, is available in multiple dosages (50 mg, 100 mg and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks), the companies said on Thursday.

It belongs to a class of drugs called phosphodiesterase type 5 inhibitors, which are used to help increase blood flow to the penis.

Vivus owns the worldwide development and commercial rights to Stendra for use in sexual dysfunction, with the exception of certain Asian countries in the Pacific Rim.

Auxilium has exclusive marketing rights to Stendra in the United States and Canada, while Sanofi SA holds a license to commercialize it in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.

The drug is sold as Spedra in the European Union.

Auxilium said on Wednesday it would not withdraw its offer to buy Canadian eye drug maker QLT Inc and adopted a poison pill, a day after receiving an unsolicited buyout offer from Endo International Plc.

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